Accelerated orthodontic apparatus and method

ABSTRACT

An apparatus and method for patients requiring repositioning of misaligned teeth who typically undergo orthodontic treatment to move the teeth into corrected positions. The orthodontic methods typically require lengthy procedures involving the application of light forces to the teeth to effect movement as accomplished by braces or other appliances. The apparatus and method includes the administration of a needle corticotomy to select regions that have been identified as absent any landmarks to avoid. The method is accomplished without the use of freeze-dried and bovine bone and without a mucoperiosteal flap procedure, resulting in low medical risk and providing a simplified and less time consuming procedure as compared to the prior art, and furthermore wherein the method effects a significant reduction in the time required to complete an orthodontic case while also significantly reducing the discomfort and recovery time for the patient.

This patent application claims the benefit of priority of priorProvisional Patent Application Ser. No. 60/522,996, filed in the UnitedStates Patent and Trademark Office on Nov. 30, 2004.

1. FIELD OF THE INVENTION

The present invention relates to an apparatus and method for performingdental procedures associated with orthodontics and, more particularly,to a method of performing orthodontic procedures in an acceleratedfashion and to apparatus useful in performing those procedures.

Orthodontics is a branch of dentistry dealing with misaligned teeth andtheir correction, typically by means of braces, aligners or similarappliances. In many orthodontic cases tooth positioning or straighteningis accomplished by means of administering light force to the tooth for aperiod of time until the tooth root moves within the jaw and isrepositioned. The tooth root is embedded in a relatively soft and highlyvascular bone in the middle of the jawbone, known as medullary bone.Both the maxilla or upper jawbone and the mandible or lower jawbone arecomprised of medullary bone surrounded by a hard exterior bone structureknown as the cortical plate of bone. The tooth is held firmly inposition by the cortical plate. Generally, by placing a light andpersistent force on a tooth for purposes of repositioning or moving thetooth relative to the maxilla or mandible, the cortical plate respondsas if an injury to the bone has occurred by softening slightly to easethe force on the tooth allowing the tooth to move thereby effecting thetooth repositioning. The softened cortical plate hardens again once theforce subsides. The hardening is indicative of healing.

This osteogenic process, wherein the bone softens and hardens, is anessential element of orthodontics. By administering a series ofincremental calculated forces to the tooth, the tooth position may begradually adjusted over a period of time.

Typically, in order to reposition misaligned teeth, the dentist willapply a series of light forces to the teeth by means of braces, wires,forms or other mechanical devices that are periodically readjusted afterthe tooth (or teeth) repositions in the now softened cortical plate. Thedevice is incrementally readjusted to apply a new light force tocontinue the movement of the tooth until the tooth moves to the desiredposition. Once the light force is removed, the cortical plate hardensand secures the tooth in the new position. The principal disadvantage isthat it takes many months, even years, to accomplish this slowosteogenic process sufficient to move the tooth or teeth into theirdesired positions.

As known to those skilled in the art, osteogenesis is induced bypersistent light force being applied to the tooth resulting in softeningof the cortical plate, thereby permitting the tooth to move.Additionally, it is known that when an additional injury is purposefullyinflicted to the cortical plate, such as the drilling or puncturing of asmall hole through the plate, the cortical plate softens around theinjury.

Corticotomy is the process of intentionally inducing injury to thecortical plate for the purpose of softening the cortical plate. Apenetration of the cortical plate permits vascular access from themedullary bone to the now exposed portions of the cortical plate therebyfacilitating rapid osteogenic repair of the injury site.

The softening of the cortical plate in an area surrounding the injurysite results in a process known as regional acceleratory phenomenon(RAP). Therefore, it is known according to prior art taught by Kole,Suya and later Wilcko to utilize multiple corticotomies (injuriesinflicted to the cortical plate) in conjunction with traditionalorthodontic techniques (to urge motion of the tooth or teeth proximatethe softened cortical plate) to accelerate the repositioning of teeth.

In essence, RAP permits more rapid repositioning of the tooth or teethby conventional orthodontic devices than would otherwise be possible. Asno one likes to wear orthodontic devices intended to move the tooth orteeth, there is strong demand to accomplish the repositioning as quicklyas possible.

Wilcko, in U.S. Pat. No. 6,109,916, described a method wherein multiplecorticotomies are administered to soften sections of the cortical platein the region of the desired tooth movement for the purposes ofsoftening the cortical plate to a greater extent than what is achievedby applying only light forces from a mechanical appliance. The increasedsoftening of the cortical plate results in an accelerated movement ofthe tooth through the cortical plate and in the underlying medullarybone thereby significantly reducing the overall time required toreposition the tooth to the desired position.

However, a significant, principle disadvantage of the prior art is therequired step of removing the gum or gingivae from the cortical plate inorder to gain access to the bone surface. As is described in greaterdetail hereinafter, removal of the gingivae from the cortical plateexposes the cortical plate to view, thereby permitting improved accuracyof the placement and application of the corticotomy (injury to thecortical plate). An improvement in accuracy is important to minimize thepotential for damage to underlying nerves, vessels, and other sensitivestructures, also known as “landmarks”, and which are described ingreater detail hereinafter.

The method to accomplish surgical removal of the gingivae is amucoperiosteal full flap procedure necessitating incisions into the gumto separate the gum from the jaw bone (i.e., from the teeth and corticalplate). Once the gingivae are lifted away from the bone, the corticalplate is exposed. The practitioner can now see sufficient variation inthe surface features of cortical plate to suggest some of the locationsof the critical landmarks that are to be avoided. The corticotomy isthen performed by penetrating or otherwise damaging the cortical platewhile avoiding the landmarks. Even so, there is risk that certainimportant landmarks may be missed by visual examination.

Then, as is further described by Wilcko, a solution of freeze-dried boneand bovine bone is applied to the surface of the cortical plate andfinally the mucoperiosteal flap is sutured back into position.

The mucoperiosteal full flap procedure inevitably causes considerabletrauma and damage to the gingivae. This trauma and damage substantiallyincrease the time for healing to occur. Raising of the mucoperiostealflap also tears the bonds that adhere the gingivae to the corticalplate, the reconnection thereof taking additional time to heal.

Furthermore, there is risk that the gingivae may not bind as tightly tothe teeth after the mucoperiosteal flap procedure as they were bondedbefore it occurred. This can cause discomfort for the patient from foodbeing wedged under the gums after the mucoperiosteal flap procedure thatwould not have occurred prior to the procedure. An inadequate bond tothe tooth can promote the growth of bacteria and cause, at a minimum,halitosis. It can also lead to an increase risk of eventually developingperiodontal disease and possible eventual tooth loss.

After the mucoperiosteal procedure and corticotomy is complete,considerable trauma has been experienced by the gingivae and,accordingly, the patient is quite uncomfortable. The patient typicallymust take considerable pain medication (usually analgesics) to reducethe substantial physical discomfort that he or she is experiencing,often for several days, after such a procedure has been performed.

Similarly, there in an increased chance for infection to occur that isgenerally proportional to the damage that has been inflicted to thegingivae. The use of antibiotics are often also administered to helpreduce this risk.

In addition, the use of dried bone or bovine bone includes the additionof a foreign body into the mouth of the patient and such inclusionincurs an additional risk of infection and possibly even rejection bythe immune system. The foreign body may also add to irritation andgeneral discomfort.

Nevertheless, to generate sufficient RAP (regional acceleratoryphenomenon) it is believed that a mucoperiosteal flap procedure must beperformed to permit viewing of the cortical plate prior to and duringthe corticotomy. The mucoperiosteal flap procedure must, according toprior art, be accomplished proximate each of the teeth that are to berepositioned.

Knowledge of the location of the important underlying landmarks isessential in order to avoid damage to those features. The prior artteaches the use of the mucoperiosteal flap procedure as necessary toreveal the surface of cortical plate prior to effecting the requiredcorticotomy.

Another disadvantage inherent with the above-described prior artprocedure is that, although the resultant view of the cortical platesurface from the mucoperiosteal flap procedure provides improvedvisualization of the landmark locations and an understanding of thegeneral anatomy of the region, there are important landmarks whichremain undetermined. Consequently, the medical risk is reduced by themucoperiosteal flap procedure, but not eliminated.

Despite full visibility of the cortical plate with the mucogingival flapused in the prior art, landmarks peculiar to a specific patient (i.e.,anomalies) may not be fully visible.

Damage to certain landmarks can cause infection, loss of sensation, andother potentially serious and irreversible problems. Such damage is aliability risk for the practitioner and that increased liability isultimately expressed through higher liability insurance premiums thatare passed on from the practitioner as increased cost to the patientassociated with any corticotomy that is intended to promote RAP, andtherefore to allow for the more rapid repositioning of the tooth orteeth.

It also takes time for the dental practitioner to perform themucoperiosteal flap procedure, and this time also contributes toincreased cost for the patient. It also increases the time the patientmust sit in the dental chair and endure a generally unpleasantprocedure. After the corticotomy is complete, there is also an increasedamount of time required to suture the gingivae. Again, this added costand related discomfort are passed on to the patient to bear.

As mentioned above, while any injury to the cortical plate may induce asoftening of the plate, to optimally induce RAP it has been found by theinventor herein that the cortical plate must be penetrated an amountsufficient to pass into a vascular area of the medullary bone and causebleeding. The resultant bleeding through the cortical plate that aprior-art practitioner observes during corticotomy and after havingperformed the mucoperiosteal flap procedure would similarly be comingfrom a vascular area of the medullary bone, although a prior artpractitioner would be hesitant to drill that deep less inadvertentcontact with a landmark occur. The mucoperiosteal flap procedure wastherefore necessary in order to verify that sufficient damage to thecortical plate had been accomplished (either a general roughening of thesurface of the plate or, if the practitioner drilled deeper into themedullary bone to ensure that penetration into the vascular area of themedullary bone had occurred). To make such determination either way thecortical plate had to be made visible and therefore the mucoperiostealflap procedure had to first be performed. Otherwise, the practitionerwould not know if the bleeding was coming from a vascular region of themedullary bone or from the gingivae.

Therefore, there exists a need for an improved apparatus and method forperforming a corticotomy to generate RAP sufficient to facilitateaccelerated orthodontic procedures while decreasing the negative effectsassociated with a mucoperiosteal flap procedure.

Clearly, such an apparatus and method would be useful and desirable.

2. DESCRIPTION OF PRIOR ART

Orthodontics, is, in general, known. Corticotomies are also known, asthe following patent describes:

U.S. Pat. No. 6,109,916 to Wilcko, et al, that issued Aug. 29, 2000.

While the structural arrangements of the above described apparatus andmethod may, at first appearance, have similarities with the presentinvention, it differs in material respects. These differences, whichwill be described in more detail hereinafter, are essential for theeffective use of the invention and which admit of the advantages thatare not available with the prior art.

OBJECTS AND SUMMARY OF THE INVENTION

It is an object of the present invention to significantly reduce theexpense required for a corticotomy assisted type of orthodonticprocedure.

Another object of the invention is to reduce the risk of infection to apatient following a corticotomy.

Still another object of the invention is to decrease the length of timefor recovery following a corticotomy.

Still yet another object of the invention is to eliminate the need foreven a partial mucoperiosteal flap surgery procedure in order to performa corticotomy.

Yet another important object of the invention is to eliminate the needfor a mucoperiosteal full flap surgery procedure in order to perform acorticotomy.

Still yet another important object of the invention is to reduce therisk of medical complications or other adverse effects arising to apatient following a corticotomy.

A first continuing object of the invention is to reduce the time that isactually required for a dentist to perform a corticotomy assistedorthodontic procedure.

A second continuing object of the invention is to reduce the duration oftime that a patient must actually endure (sit in the dentist's chair) inorder to perform a corticotomy assisted orthodontic procedure.

A third continuing object of the invention is to eliminate the need forthe placement of bone grafting material adjacent to the cortical plateproximate the areas of injury to the plate associated with acorticotomy.

A fourth continuing object of the invention is to reduce the discomfortthat a patient experiences during a corticotomy assisted orthodonticprocedure.

A fifth continuing object of the invention is to reduce the level ofdiscomfort that a patient experiences after having had a corticotomyassisted orthodontic procedure.

A sixth continuing object of the invention is to allow a dentist toperform a corticotomy without removal of the gingivae from the jawbone.

A seventh continuing object of the invention is to facilitate thelocation of landmarks prior to a corticotomy.

An eighth continuing object of the invention is to provide an apparatusthat is useful in avoiding landmarks during corticotomy.

A ninth continuing object of the invention is to provide a method thatdetermines the location of landmarks to avoid during corticotomy.

A tenth continuing object of the invention is to provide a method forperforming corticotomy by drilling directly through the gingivae.

An eleventh continuing object of the invention is to provide a templatethat is placed over at least a portion of the teeth and gingivae that isuseful in avoiding landmarks during corticotomy.

A twelfth continuing object of the invention is to provide a method thatuses a CTscan (also sometimes referred to as a “CAT scan” or as a “CTscan”) to create a file of at least a portion of the jawbone of apatient in need of orthodontic treatment, and wherein the file includesan indication of any possible landmarks to avoid contacting duringcorticotomy.

A thirteenth continuing object of the invention is to provide a methodthat uses a CTscan to create a file of at least a portion of the jawboneof a patient in need of orthodontic treatment and wherein the file canbe used to create a virtual image of the portion of the jawbone.

A fourteenth continuing object of the invention is to provide a methodthat uses a CTscan to create a file of at least a portion of the jawboneof a patient in need of orthodontic treatment and wherein that file canbe used to provide indication as to where to drill through the gingivaeand avoid landmarks.

A fifteenth continuing object of the invention is to provide a methodfor x-raying at least a portion of a jawbone of a user prior tocorticotomy, and of using the data acquired to avoid landmarks.

A sixteenth continuing object of the invention is to provide a methodfor x-raying at least a portion of a jawbone of a user prior tocorticotomy, and of using the data acquired to provide indication duringthe corticotomy where a dentist can drill through the gingivae andthrough the cortical plate and into the medullary bone underneath whileavoiding landmarks.

A seventeenth continuing object of the invention is to provide a methodand apparatus for indicating where a dentist may drill through thegingivae and through the cortical plate and which also indicates thedepth of drilling that is desired.

An eighteenth continuing object of the invention is to provide a methodand apparatus for x-raying at least a portion of a jawbone of a userprior to corticotomy, and of using the data acquired (image file) toprovide indication during the corticotomy where a dentist can drillthrough the gingivae and through the cortical plate and how deep intothe medullary bone the drill may pass sufficient to draw blood and beginRAP while avoiding certain landmarks.

A nineteenth continuing object of the invention is to provide anapparatus that regulates the depth of drilling at each bore site throughthe gingivae and through the cortical plate to a depth that is preferredat each location.

A twentieth continuing object of the invention is to provide anapparatus and method that ensures that when drilling through thegingivae and into the cortical plate the penetrations are made only inthe interproximal regions between the roots of two adjacent teeth.

A twenty-first continuing object of the invention is to provide anapparatus and method that permits corticotomy to safely occur bydrilling directly through the gingivae, the cortical plate, and into themedullary bone.

A twenty-second continuing object of the invention is to provide anapparatus and method that eliminates the need for a bone graft for aperson with normal height and density of alveolar bone.

A twenty-third continuing object of the invention is to provide anapparatus and method that improves the detection of the location of theanatomical landmarks to be avoided while performing a corticotomy.

A twenty-fourth continuing object of the invention is to provide anapparatus and method that permits the detection of unusual or oddlylocated landmarks peculiar to a specific patient (anomalies).

A twenty-fifth continuing object of the invention is to simplify theprocedure for an accelerated orthodontic procedure.

A twenty-sixth continuing object of the invention is to simplify theprocedure for an accelerated orthodontic procedure sufficient to permitwidespread use of such procedure by the mainstream of practicingdentists.

A twenty-seventh continuing object of the invention is to reduceapprehension for the prospective patient regarding any of the high cost,complexity, discomfort, or risks of prior art techniques to provideaccelerated orthodontic procedure.

A twenty-eighth continuing object of the invention is to provide anapparatus and method that lessens damage to the gingivae duringcorticotomy.

A twenty-ninth continuing object of the invention is to provide anapparatus and method that is adapted to use a laser to penetrate throughthe gingivae and cortical plate.

A thirtieth continuing object of the invention is to provide anapparatus and method that uses 3-D imaging software to generate from aCTscan, x-ray, or other type of imaged file a positive structure of thesize and shape of at least a portion of the jawbone of a patient usefulin the determination of where to drill through the cortical plate.

A thirty-first continuing object of the invention is to provide anapparatus and method that that uses 3-D imaging software to generatefrom a CTscan, x-ray, or other type of imaged file a positive structureof the size and shape of at least a portion of the jawbone of a patient,and wherein the structure that is produced is sufficiently transparentto reveal the location of certain landmarks in the jawbone.

A thirty-second continuing object of the invention is to provide anapparatus and method that that uses 3-D imaging software to generate apositive structure of the size and shape of at least a portion of thejawbone of a patient, and wherein the structure is sufficientlytransparent to reveal the location of certain landmarks in the jawbone,and wherein the structure is for use in creating a template to indicate,during corticotomy, safe interproximal regions for drilling through thegingivae and through the cortical plate.

A thirty-third continuing object of the invention is to provide anapparatus and method that uses imaging technology to provide a real-timeindication to a dentist where it is safe to drill through the gingivaeand through the cortical plate.

A thirty-fourth continuing object of the invention is to provide anapparatus that provide a template that is placed over at least a portionof the jawbone of a patient, and wherein the template provides depth anddirectional information to the dentist sufficient to permit the dentistto drill through the gingivae and cortical plate into the medullary bonewhile avoiding landmarks in the medullary bone.

A thirty-fifth continuing object of the invention is to reduce the riskof damage to landmarks during corticotomy.

A thirty-sixth continuing object of the invention is to provide a methodand apparatus for indicating where a dentist may drill through thegingivae and through the cortical plate and which also provides means tolimit the depth of drilling of each that is accomplished to an vasculararea in the medullary bone.

A thirty-seventh continuing object of the invention is to provide amethod for drilling through the gingivae and through the cortical plateand into a vascular region of the medullary bone and without having torely on visual observation of the surface of the cortical plate toensure that drilling to a sufficient depth has occurred.

Briefly, an apparatus useful for corticotomy that is constructed inaccordance with the principles of the present invention includes atemplate that is placed over at least a portion of the teeth andgingivae of a patient. The template includes visual indication where itis safe to penetrate (i.e., to drill) through the gingivae and throughthe cortical plate in an interproximal region of the cortical platebetween at least two adjacent teeth sufficient to penetrate into themedullary bone and to induce RAP. Modifications are described to thetemplate that include depth regulation and directional information.Different methods of making the template are also described.Accordingly, a method for performing corticotomy without the requirementof a mucoperiosteal flap procedure is described in which drillingthrough the gingivae and cortical plate is accomplished while avoidinglandmarks. Modification is described where use of the template is notrequired and whereby other real-time indications as to location fordrilling are provided on the gingivae during the procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification illustrate embodiments of the invention and,together with the description, serve to explain the features,advantages, and principles of the invention.

FIG. 1 is a perspective view of an embodiment of the surgical templateapparatus in accordance with this invention with markings indicating theregions suitable for penetration of the gingivae and subsequently theunderlying cortical plate.

FIG. 2 is an upper anterior view of the cortical regions showing thespatial relationship between the triangle region and the surroundinganatomical features of a patient.

FIG. 3 is a right buccal view of a lower or mandibular model of a jawwith the cortical regions projected on the surface of the mucogingivalmodel revealing the underlying landmark features and anatomy of apatient.

FIG. 4 is frontal view of the surgical template showing the corticalregion openings.

FIG. 5 is a right buccal view of the surgical template.

FIG. 6 is an occlusal view of the surgical template.

FIG. 7 is a left buccal view of the surgical template.

FIG. 8 is an internal view of the surgical template of FIG. 7 as seenfrom above.

FIG. 9 is a frontal view of the surgical template in position with anX-tip needle perforating the gingivae and underlying cortical plate ofbone through a cortical region that has been projected to a cut outregion in the template.

FIG. 10 is a cross-sectional view of a modified template showingalternate ways of controlling depth and hole placement and angle ofpenetration.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now on occasion to all of the FIGURE drawings, the presentinvention provides an apparatus and a method of accomplishing animproved corticotomy facilitated orthodontic procedures. According to apreferred embodiment, a surgical template 20 (FIG. 1) is securelypositioned over a patient's teeth and gums (also referred to herein asgingivae and identified by reference numeral 83, FIG. 3) and isconstructed so as to indicate the regions of the gums 83 which may besafely penetrated, in numerous locations, passing then through acortical plate and into an underlying medullary bone within a jawbone(66, FIG. 2), by a small drill or needle (102, FIG. 9) thereby effectingthe corticotomy.

The use of the small drill 102 or needle 102 is referred to as a needlecorticotomy. After the corticotomy is completed, the patient's corticalplate softens, as known to those familiar with the art, within typically1 to 7 days an amount sufficient to begin moving the teeth in anaccelerated manner by means of the application of light forces using anyof the currently available conventional orthodontic techniques. Futuredevices to assist the movement of teeth may also be developed and usedin conjunction with the instant invention.

The cortical bone remains soft for a period of time, thereby permittingfaster movement of the teeth in response to light forces that areapplied to them to urge them in the desired direction.

Continuing now to refer in greater detail to the various FIGURES whereinlike reference characters refer to like parts, there is shown at 20 inFIG. 1, the surgical template constructed in accordance with the subjectinvention.

An accelerated orthodontic procedure is facilitated by performing acorticotomy involving the perforation of a patient's cortical plate. Adetailed description of a corticotomy, in general, is not includedherein other than to describe the differences thereto that arise fromuse of the instant invention as it relates to a needle corticotomybecause corticotomies are generally well known to those having ordinaryskill in the dental arts.

Referring momentarily to FIG. 2, the jawbone 66 includes at the surfacethe cortical plate which includes a thickness that varies patient topatient, as described in greater detail hereinafter. Covering thecortical plate are the gingivae 83 or gums. Protruding from the corticalplate are the various teeth (62, 64 FIG. 2).

Underneath the cortical plate is the medullary bone where each tooth's62, 64 root 68, 70, FIG. 2, are disposed. The medullary bone containsany of a variety of landmarks (one landmark is shown in FIG. 3,reference numeral 90) that are to be avoided. The various landmarks toavoid are well known to those having ordinary skill in the dental arts.Serious harm to the patient can occur if certain of these landmarks arecontacted during the corticotomy.

A primary advantage, as is described in greater detail hereinafter, isthat the instant invention permits the desired corticotomy to occurwithout the removal of the mucogingival tissue 83. The improved needlecorticotomy is accomplished by penetrating the mucosal tissue (gums 83)and the underlying cortical plate at very specific locations and in veryspecific directions as indicated by the surgical template 20. Thetemplate 20 is custom made (molded) to precisely fit each patient and ispositioned over the teeth 62, 64 and gums 83 after the landmarks (toavoid) have first been identified, as described in greater detailhereinafter, and factored into design of the template 20.

FIG. 1 provides an overall perspective view of the surgical template 20,showing its major features and their spatial relationships.

Further referring to FIG. 1, the surgical template 20 is so engineeredto present targeted areas through which penetrations using the needle102 or drill 102 or by other means, as described in greater detailhereinafter, may be made with assurance that the key anatomicallandmarks will be avoided. These preferred areas are used to guide thedentist as he or she drills through the patient's gingivae 83 and alsothrough the patient's cortical plate beneath the gingivae 83. Theseareas are exemplified by a plurality of regions 22, 24, 26, 28, 30, 32,34, 36, 38, 40, 42, 44, and 46.

These regions 22-46 are of any preferred or desired size and shape andthey will vary from patient to patient, depending on the general orunique location of the landmarks. Often, the regions 22-46 will have acommon shape that resembles either a triangle or a “tall” type of atrapezoid. However, depending on the unique landmarks that a particularpatient may have, the shape of any of the regions 22-46 will vary, asdesired. Some of the regions 22-46 may resemble a square or arectangular, whereas some may be more oval or circular, or include anyconceivable type of a polygonal shape. The shape of any one region 22-46may vary significantly from the shape of any adjoining region.

The regions 22-46 are included on the surgical template 20 in two basicways. There is a third way to indicate the regions, discussed in greaterdetail hereinafter, which does not utilize the template 20 or anyvariation thereto.

Each patient differs anatomically and therefore the surgical template 20is constructed specifically to correspond to the unique anatomicalfeatures of each patient. The surgical template 20 is generallycomprised of a molded element that closely follows the contours of thepatient's teeth 62, 64 (and other teeth) and gingival 83 regionsproximal to the teeth 62, 64 that are to be repositioned.

The surgical template 20 is made to “form-fit” to the patient's specificanatomy. As shown throughout the drawings, the template 20 extends thelength of either the upper or lower jawbone 66. This is generallypreferred to ensure that a firmer or better fit occurs. However, ifpreferred, a smaller, shorter, or other specific section of the template20 can be used when only one or two teeth are to be repositioned and amore localized corticotomy is required. It is also important to notethat the template 20 is preferably saved even after the corticotomy isperformed.

The needle corticotomy is intended to soften the cortical plateproximate areas of injury to the plate by producing regionalacceleratory phenomena or RAP, as is discussed further hereinafter. If,however, it is determined that after having performed a needlecorticotomy, as described herein, there is insufficient RAP occurring,the template 20 may be reused and a repeat needle corticotomyaccomplished at any site (i.e., at any particular region 22-44) whereRAP has slowed down after 90-120 days. Therefore, the template 20 issaved for possible future use.

The preferred method of constructing the surgical template 20 is the useof CAD/CAM technology which consists of a CTscan to create an imagefile. The image file is used to create a virtual 3D model of each (upperand lower) jawbone 66 depicting also all of the teeth 62, 64, roots 68,70, critical landmarks 90 and cortical regions 22-46 over aninterproximal bone 60 (FIG. 2). Computer software is used for thispurpose and is known. The surgical template 20 is then virtually createdto fit a virtual model of the jawbone 60. This information is stored ona CD-ROM and is then used to create an actual physical model of each jawand then an actual physical surgical template (i.e., a variation inconstruction that is still used as the template 20) is created to fiteach jaw, which includes each physical model made from the image file aswell as each of the patient's actual jawbones 66. The actual physicalmodel of each jaw is preferably created using a clear plastic type ofouter material with landmarks shown in color within the model. Thatmakes it easy, when constructing the template 20, to create the regions22-46 that avoid the landmarks. As is described in greater detailhereinafter, an effective way to produce the physical models is by theuse of stereo-lithography.

One possible way to create the surgical template 20 is for the dentistto take an impression (well known) of the patient's teeth 62, 64 andgums 83 and then construct a plaster model (not shown) from theimpression. The plaster model is then used to form the surgical template20 over the plaster model using a thermo-suction technique (well known).

It is also known how to construct a virtual model of a jaw and then aphysical model using the CTscan image file. This practice has been usedwhen an implant, used to replace a missing tooth, is implanted into ajaw and the dentist must drill down from the top of the jaw. Thesoftware to generate the preferred view of the jawbone used for theinvention as described herein is obtained by modification to thesoftware.

There are other well known techniques and methods that can readily beadapted to create the desired template 20. For example, vacuumthermoforming techniques using an Essix Brand Vacuum Machine (at theworldwide web at essix.com) can also be used to form the template 20over a model of the jawbone 66. A plastic sheet is thermoformed onto aplaster model of the patient's gums and teeth, thereby providing a baseto be used to create the actual finished template 20. Landmarks arelocated by x-ray or CTscan and are then superimposed on the templatebase.

It is not necessary to indicate the location of the landmarks on thetemplate 20, however, they can be included, if desired. It is, however,necessary to assist the dentist in providing areas that are safe todrill into which will avoid these landmarks. While including all of thelandmarks on the template 20 and allowing the dentist to drill aroundthem is possible, it is not preferred.

Rather, it is preferred that the regions 22-46 be included on thetemplate 20 that reveal areas that are “safe” to penetrate through thegingivae 83, through the cortical plate, and into the vascular regionsof medullary bone underneath. In other words, it is preferred to showthe dentist areas where it is safe to drill rather than to show areas toavoid drilling. It also improves safety by showing the safe regions22-46 because those areas that are shown as safe to drill into on thetemplate 20, that is the regions 22-46, include a safety margin thathelps ensure that the dentist will stay sufficiently far away from keylandmark areas, for example, from roots, nerves, vessels, sinus areas,etc.

The template 20 is preferably constructed of a sheet of transparentplastic to allow viewing of the teeth 62, 64 and gums 83 over which itis applied; however, other moldable materials may also be suitable. Thematerial used to form the template 20 is preferably of sufficientthickness and rigidity so as to maintain its form when it is appliedover the teeth 62, 64 and gums 83. According to a modification,described further hereinafter, the thickness becomes a variable.

Continuing to refer now in particular to FIG. 2 is shown, amongst otherelements, the typical anatomical features of a patient. Regions of thecortical plate determined to be safe to penetrate are determined and areprojected to the surgical template as the regions 22-46 in the template20.

It is to be understood that not every tooth is necessarily repositionedduring any orthodontic procedure and that therefore, not all of theregions 22-46 will always be utilized during corticotomy. In general, ifa tooth is to be urged in any given direction as part of the orthodonticprocedure, the needle corticotomy is performed minimally on the side ofthe tooth in the interproximal bone 60 where migration of the tooth isdesired. However, the needle corticotomy is preferably performed on bothsides of the tooth that is to be repositioned.

Additionally as mentioned earlier, the regions 22-46 are presented ineither of three ways. Two of those ways are used with the template 20; athird way is described as a modification hereinafter. A preferred way isto provide a cut-out of the region where corticotomy is to occur. Thedentist performing the orthodontic procedure determines this. Needlecorticotomy may occur between many, most, all or only a few of theteeth. Only select regions 22-46, where the corticotomy is to occur,will appear on the template 20. This is to avoid confusion and thepossibility that excess corticotomy could occur between teeth that donot require RAP.

In some cases the same dentist performing the orthodontic procedure willalso perform the corticotomy, as described herein. This, of itself, isan improvement over the prior art wherein when practicing corticotomywith the prior art a more skilled practitioner, one who was able toperform the mucoperiosteal flap procedure, was required to perform thecorticotomy. This procedure was more daunting and complex than manydentists would care to engage in. The instant invention allows thosedentists who would not feel sufficiently skilled to perform amucoperiosteal flap procedure to accomplish the type of needlecorticotomy disclosed herein.

According to a preferred way of indicating the regions 22-46 on thetemplate 20, each region 22-46 where corticotomy is to occur is cut outor removed to provide an opening or plurality of openings through thetemplate 20, exposing the gingivae 83 directly underneath. As describedin greater detail hereinafter, the dentist would simply use each cut-outregion 22-46 to drill a plurality of holes through the gingivae 83,cortical plate, and down into the medullary bone.

According to a preferred way of indicating the regions 22-46 on thetemplate 20, each region 22-46 where corticotomy is to occur is outlinedon the template. The dentist would similarly use each region 22-46 todrill a plurality of holes that first pass through the template 20itself ensuring that each of those holes occurs within one of theoutlined regions 22-46. After puncturing the template 20, the dentistwould continue drilling through the gingivae 83, cortical plate, anddown into the medullary bone.

FIG. 2 shows a safe area 50 between the roots of two teeth 62, 64 thatincludes a generally trapezoidal overall shape. It also tends toresemble a triangular in shape as well. The safe area 50 as determinedto exist between any two of the adjacent teeth 62, 64 is used to defineeach of the regions 22-46 that appear on the template 20.

The safe area 50, once determined, is projected onto the surgicaltemplate 20. The safe area 50 is generally defined by outlining theinterproximal bone 60 between the adjacent teeth 62 and 64 as viewedfrom the buccal or labial view of the jaw bone 66. The safe area 50 isfurther defined by the surfaces of the roots 68 and 70 of adjacent teeth62 and 64 on the sides, an upper apex 72 of the cortical triangle beingdefined by the gingival crest of the bone and a lower delineation 74being preferably defined by a line drawn from a point approximately ¾the distance of the root length of one tooth to a similar point on theadjacent tooth as measured from the base of a crown 74 and 76 where theroot begins towards the apical end of the root 78 and 80. If anatomicalfeatures to be avoided are determined to lie within the safe area 50,the boundaries of the safe area 50 are adjusted to exclude thosefeatures and the adjusted safe area 50 is then projected onto thetemplate 20 where it is either outlined (to drill through the template20 and through the gingivae 83, cortical plate, and to the medullarybone) or the projected safe area 50 is cut out and removed from thetemplate thereby allowing the dentist to drill directly into thegingivae 83 and continue through the cortical plate and into themedullary bone.

Experiments have shown that limiting corticotomies to the safe areas 50(i.e., the regions 22-46) is sufficient to produce adequate softening ofthe cortical plate to permit accelerated tooth repositioning (RAP). Thetotal number of guide regions 22-46 in the template 20 will bedetermined on a case by case basis as required to soften the appropriateinterproximal cortical plate bone regions.

As in FIG. 2, the lower delineation 74 may alternatively be defined by aline 82 drawn from the apex of the root of one tooth 78 to the apex ofthe adjacent root 80; however, landmark features, which tend to be moreprevalent closer to the root apex, such as nerves maybe located in thisregion and care must be taken to avoid these structures. Other potentialcomplications of placement of the lower delineation 74 as defined fromadjacent root apexes have been observed such as an increased difficultyin penetrating the more delicate mucogingival tissues 83 residing overthe apical end of the root as the tissue itself tends to wrap around thedrill 102 during penetration.

The use of the well fitting surgical template 20 with a closed borderapproximately ⅛″ beyond the safe area 50 helps to prevent wrapping ofthe delicate mucogingival tissue in the apical area. Further, a thicker,harder plastic material, if used to create the template 20 provides anadded benefit. The template 20 also holds the mucogingival tissue evenfirmer, which further protects the tissue from wrapping around the drill102.

Another solution to minimize the wrapping of the delicate mucoperiostealtissue, aside from drilling through the template 20, is to limit thesize of the regions 22-46 that have been cut out to a minimal amount.This is done by creating holes within the borders of the safe areas 50instead of a complete cut out of the plastic surface of the surgicaltemplate 20 over the safe area 50, which is also the border of theunderlying interproximal bone.

This design approach provides a preferred method for providing access tothe dentist when penetrating the gingivae 83 and cortical plate of bone,first, because it holds the mucoperiosteal tissue 83 more firmly whichlimits the wrapping effect, and secondly, because the holes that are tobe drilled through the template can be color coded which provides theoperating dentist with a depth guide.

The depth guide referred to here is particularly useful when atransparent virtual or physical model of the jaw is provided to thedentist, along with the surgical template or guide, since the 3D imagingsoftware allows the software technician (who creates the virtual andactual physical models of the patient's jaw) to measure the depth of themucosal tissue as well as the depth of the cortical plate of bone thedentist is penetrating to reach the vascular medullary bone beneath thecortical plate of bone.

Referring to FIG. 3, showing a right buccal view of the regions 22-46(46 being identified) are projected onto the surface of the workingmodel. The landmark anatomical features such as a mandibular canal 90are thereby avoided. The projected safe areas 50 form the regions 22-46and those regions where corticotomy is to occur are then cut out (or,alternately, outlined on) from the surgical template 20, thus formingthe openings (or, alternately, the outlined areas) through whichpenetrations can safely be made without the need for mucoperiosteal flapprocedure.

FIG. 4 shows a frontal view, FIG. 5, a right buccal view, and FIG. 6, anocclusal view of the surgical template 20 illustrate the close formfitting construction of the template to the patient's anatomy andprovide alternate views of the cut out regions. Forming the plastictemplate 20 tightly around the teeth and gingivae 83 allows the template20 to be held in place and in the correct position on the patient. Theexact dimensions of the template 20 and the cut out regions will, ofcourse vary, depending upon the specific anatomy of the patient.

Also, and as mentioned earlier, for certain situations where the needlecorticotomy is to be performed at only a few locations, a smallersection of the template 20 (i.e., not including all of the teeth) may beprovided, if preferred. If a smaller section of the template 20 is used,it must nevertheless include a sufficient number of teeth or otheranatomical features of the patient so as to ensure that the smallersection is properly aligned in the patient's mouth. The smaller section,as well as the full template 20 cannot be allowed to excessively move orshift in its position while it is affixed over the patient's teeth 62,64 and gums 83. This is because it is important to maintain the fewregions 22-46 (i.e., those few that are included in the smaller sectionof the template 20) in their proper position over the interproximal bone60 and away from all of the landmarks 90 it is desirable to avoid.

It is also noted that more than one template 20 can be used. Forexample, a first version of the template 20 (or a first section of thetemplate 20) may be used to assist in performing a needle corticotomywith the upper jawbone (i.e., Maxillary). The first version of thetemplate 20 would then provide a Maxillary version of the surgicaltemplate 20. A second, different version of the template 20 (or a secondsection of the template 20) may be used to assist in performing a needlecorticotomy with the lower jawbone (i.e., Mandibular). The differentversion of the template 20 would then provide a Mandibular version ofthe surgical template 20. This is useful when teeth are to berepositioned in both the upper and lower jaws.

It is also possible to use a first section of the template 20 on oneside of either the upper or lower jawbone and to simultaneously use asecond section of the template 20 on another side or location of theeither the same upper or lower jawbone. This is when one or two teethare to be repositioned on the same jawbone but when these teeth aresufficiently separated from each other. The use of two sections of thetemplate 20, as described, may be used in this situation although it isstill preferred to use one continuous version of the template 20, asshown. These options are discussed herein to illustrate a few of thevariations in the apparatus and method that are possible for thoseskilled in the art.

When the teeth of any particular patient are deemed to be especiallycrowded, the dentist may elect to cut the template 20 (either theMandibular or the Maxillary versions thereof) into two or three sectionsto permit easier placement of the sections of the template 20 over thecrowded teeth.

Referring now to FIG. 7, a left buccal view of the surgical template 20,a gingival portion of the template is indicated by bracket 129. Thegingival portion 129 is that section of the template 20 that rises abovethe gum line or gingival crest on the Maxillary or upper version of thetemplate 20 and which covers the gingivae 83 that are disposed over thecortical plate in the area of interest, namely where the needlecorticotomy is to be performed. The gum line is indicated by marker 131.The gingival portion 129, of course, extends down from the marker 131 onthe Mandibular or lower version of the template 20. The gingival portion129 may also be generally referred to as a mucogingival or as amucoperiosteal portion of the template 20.

A mucosal extension 132 optionally protrudes from one or both ends ofthe gingival portion 129 of the template 20 when an additional region,as shown by dashed line 133, is included and when needle corticotomy isrequired through the additional region 133. The mucosal extension 132provides an extension to the gingival portion 129 to provide thenecessary guidance and also, to stabilize the gingivae 83 underneath themucosal extension 132 sufficient to prevent it from wrapping around thedrill 102.

Referring now to FIG. 8, an internal view of a surgical template 20,shows the plurality of indentations around the teeth. These indentationsare the spaces into which each respective tooth fits. Such a space isexemplified by reference numeral 92. It is important to understand thatthe template 20 is thermoformed (or otherwise produced) so as to providea plurality of the spaces 92 that conform well to the shape, location,and volume of each tooth. Accordingly, the template 20 fits over theteeth and gums with precision and it is retained in place by theprecision of its fit.

The surgical guide (i.e., the template 20) thereby indicates the areasinto which penetrations of the gingivae may be made without injuringsensitive, predetermined landmark features.

FIG. 9 shows a frontal view of a Maxillary version of the template 20 inposition disposed precisely over a patient's teeth and gums. Assumingthat needle corticotomy is to be performed at region 36 (as shown inFIG. 9; the region numbers may change with each version of the template20), it is preferred that a plurality of penetrations (i.e., holes thatare drilled) occur at region 36 and also at each remaining regionwherever corticotomy is to occur. This may include only one or two ofthe total number of regions 22-46 or it may extend up to and includingall of the regions 22-46. Again, this is determined on a case by casebasis.

The reason a plurality of penetrations is preferred to just onepenetration at any given region (i.e., region 36) is because it ishighly desirable to enter into a vascular region of the medullary boneand cause it to bleed. When bleeding of the medullary bone occurs,conditions for generating RAP are optimized.

In particular, the cortical plate of bone is avascular. By penetratinginto the medullary bone, a blood supply is provided to the corticalplate. Osteoblasts are then sent to the cortical plate in sufficientlylarger numbers which results in RAP or “regional acceleratoryphenomenom” and allows the teeth to move (reposition) faster whenorthodontic forces are subsequently applied.

Therefore, a plurality of penetrations, spaced 3-4 mm apart, areaccomplished through the gingivae 83, through the cortical plate, andinto the medullary bone underneath the region 36 to adequately softenthe interproximal bone.

Also, it is possible to observe bleeding and conclude, with a highdegree of accuracy, that it is originating in the medullary bone.

A number of penetrations are next made into and through the gingivae 83that is exposed in the region 36. In general, each penetration is madeas close to perpendicular with respect to the surface of the gingivae 83as is possible. According to a preferred embodiment, the gingivae 83that is to be punctured is exposed by the cut out area (i.e., the region36) in the surgical template 20.

While variation is possible, a preferred way to make the punctures is byusing a small diameter needle-like instrument, for example a productmarketed as an X-Tip® 104 and as shown in FIG. 9, or #2 small round bur,or similar drill. The X-Tip® 104 is shown mounted in a slow dentalhandpiece 100 and in the preferred position (i.e., perpendicular tosurface) to perform a penetration though the gingivae and through theunderlying cortical plate, passing beyond the cortical plate and in tothe underlying inner or medullary bone.

The cortical plate usually is from 1 mm to 2 mm thick and typicallyrequires a 4 mm long needle or drill shaft 102 to penetrate through thegingivae 83, cortical plate, and sufficiently far into the medullarybone. When portions of the cortical plate are determined to be harder orthicker than that suitable for penetration by an X-Tip®, experimentshave shown that a small round burr or other type drill is indicated andmay, of course, be substituted therefore.

The needle or drill, as mentioned above, is generally insertedperpendicular through the gingivae 83 into the underlying cortical plateand subsequently into the underlying medullary bone. Experiments haveshown best results when penetrations are made at approximately 3-4 mmspaced-apart distances within the region 36 and when the penetrationsoccur in sufficient number within the surgical template 20 cut outregion 36 to maximize the occurrence of RAP and the associated softeningof the cortical plate.

Softening of the cortical plate shortly after the needle corticotomy isperformed requires about one week to reach the level of regionalacceleratory phenomena or RAP, which as mentioned hereinbefore resultsin the rapid softening of the cortical plate thereby allowingaccelerated repositioning of the teeth using orthodontic appliances suchas braces or the aligners sold under the tradename, Invisalign®.

Experiments have further shown that after a needle corticotomy,softening of the cortical plate is sustained for approximately 90 to 120days before re-hardening begins to secure the teeth in their newpositions. It is noted that a slight pressure is maintained on thecortical plate during at least a portion of this period of time by theorthodontic appliances that are used. It is, of course, possible thatre-hardening might occur sooner in the absence of these sustained slightforces by the teeth themselves.

It is possible, also, for re-hardening to occur sooner than desired,even when slight pressure is applied to the cortical plate by the teeth.If the cortical plate re-hardens before the orthodontic procedure iscompleted, the surgical template 20 or a section of the template 20 canbe positioned again over the affected teeth that require additionalmovement and for the needle corticotomy to again be performed in theareas (i.e., regions 22-46) that require it.

An advantage provided by the instant apparatus and method is that theneed for post-operative dressing or treatment is either greatly lessenedor entirely eliminated after the minor surgical procedure (i.e.,puncturing of the gingivae 83) has been completed. The usual pain andantibiotic medications used for other common types of dental proceduresis usually sufficient to give the patient comfort and protection frominfection.

By way of contrast, the prior art method using a mucoperiosteal fullflap surgery, however, is much more invasive and the potential forinfection far greater.

There are two ways to determine the depth of drilling that is requiredand they are either by approximation or by some form of measurement. Asdescribed above, the template 20 shows where to drill but it does notshow how deep. Neither does it show how many holes to drill in any givenregion 22-46. The practitioner uses his skill to make such determinationand this is generally a very acceptable approach. It is important tonote that the regions 22-46 have already excluded the landmarks that areto be avoided so a slight variation in angle (away from perpendicular)or depth is of little concern.

It is possible to use the image file (described hereinabove) to moreprecisely define both the number of penetrations that are to occur inany given region as well as the depth of each penetration, separate anddistinct from the next penetration. Before a discussion of this occurs,the following description is useful in explaining how the detailed imagefiles, useful in creating the template 20 or any variation thereto, areobtained.

The interproximal bone 60 regions that are safe to penetrate areidentified by various means, for example by x-rays, MRI, ultra-sound, CT(or CAT) scans or other currently recognized diagnostic techniques aswell as by future diagnostic techniques for visualizing or locatinganatomical landmark features to be avoided during penetration of thecortical plate.

The preferred method of creating and manufacturing a surgical guide foruse in the present invention is as follows: A CT scan is taken of thepatient's upper and lower jawbones and teeth. The scan is formatted andusing 3D CAD/CAM software, a virtual model of each of the jawbones iscreated virtually showing the jawbone in transparent plastic with agingival layer, teeth, roots and critical landmarks visible to the enduser. The gingival layer, teeth, roots and critical landmarks arepreferably delineated within the transparent plastic sufficient to bereadily observed. The interproximal bone 60 between all of the roots isalso visible.

A safe area 50 is then drawn on the virtual model over eachinterproximal bony 60 area between any two adjacent teeth 62, 64 wherecorticotomy is to occur. Using 3D software to create a virtual model ofeach jawbone allows for the creation of different views to optimallydisplay the density and depth of the cortical plate, thereby allowing“virtual holes” (penetrations) of varying circumference and depth to beplaced through the gingivae and cortical plate in all of the intendedinterproximal bone 60 areas of the jawbones. The location of the virtualholes is in conjunction with those interproximal bony 60 areas adjacentto teeth 62, 64 that are misaligned and are in need of orthodonticmovement. It is also possible to determine an ideal “virtual depth” foreach penetration.

Based on the depth necessary for the end user to penetrate the corticalplate, each virtual hole is color coded to indicate the preferred depththat the drill must penetrate to optimally penetrate the cortical plateinto the medullary bone. The selection of color codes is determined bynumber of millimeters the X-tip® or #2 round bur or other drill must bedriven to penetrate the cortical plate. For instance, 2 mm length holescould be green, 4 mm holes could be yellow and 6 mm holes could be red.A file of this information is then saved and stored on a CD-ROM for usein the physical construction of the models and surgical guides (i.e.,template 20).

The most accurate and cost effective method for creating a large volumeof surgical template 20 guides for end users is by the process ofstereo-lithography. Using the CD-ROM file (of course the CD-ROM filecould be stored otherwise and emailed, for example), an actual physicalmodel of each jawbone is manufactured, which includes all of the beforementioned features and qualities of the virtual models. The full scalemodel is constructed of transparent material allowing a 3D visualizationof the patients' anatomy. A surgical template 20 is then constructed tofit each physical model of each jawbone.

Each of the safe areas 50 are then projected onto the surgical template20 and included as one of the regions 22-46. As mentioned earlier, anyone of the regions 22-46 may include any particular shape although agenerally triangular shape (or trapezoidal) is most common.

Depending on the preference of the end user practitioner, holes ofvarying depths and colors are made through the surgical template. Inother words, each of the plurality of individual holes that are to bedrilled in any or every particular region 22-46 is pre-drilled throughthe template 20. After the practitioner places the template 20 over thepatient, he or she simply holds the drill 102 perpendicular and drillsthrough each of the pre-drilled holes in the template 20 that have beenprovided in each region 22-46. An advantage of pre-drilling the holes inthe template during its manufacture (as opposed to providing the largercut-out region) is that the gingival portion 129 provides greatersupport for the gingivae 83 virtually elimination the possibility thatthe gingivae 83 will wrap around the drill 102.

However, as previously described, if the end user prefers, a completecut-out of each particular region 22-46 is alternately made in thetemplate 20 thereby allowing the end user to choose the locations forpenetrating the cortical plate.

Another alternate method to produce the template 20 is to take digitalx-rays of the patients' teeth and jawbones in the regions where theteeth are to be repositioned. The x-rays are scaled to full size in acomputer graphics program such as Microsoft Photodraw®. The anatomicallandmarks are identified on the x-rays and the safe areas 50, used todefine the regions 22-46, are defined and included.

A template element (the basic template sheet that conforms to thepatient's anatomy, prior to its completion) is constructed using asimple vacuum thermoforming machine to suction a moldable plastic sheet(readily moldable at temperature) over a plaster model of the jawbonewhich the dentist makes from simple impressions of the patients' teethand gums that he or she has taken.

Another example of a prior art type of device that can be modified foruse to create the template are bleach trays, currently used to house asolution of bleach used to whiten teeth. Of course additionalmodifications to the trays, consistent with the disclosure herein, mustbe first accomplished.

The safe areas 50 where corticotomy is required are then projected ontothe template element by placing the x-ray images over the templateelement. The regions 22-46 are then mapped and marked on the templateelement to indicate the cut-out regions. The regions 2-46 are thencut-out (i.e., removed) from the template element to produce the actualtemplate 20. The cut-out regions 22-46 thus reveal the safe areas 50 forneedle or drill penetration to occur.

Holes, as mentioned hereinbefore, can alternately be drilled through thesurgical template 20 during its manufacture if the end user prefers thismethod over a full cut out. Although not preferred it is possible, asalso mentioned hereinbefore, to simply outline the regions 22-46 on thetemplate 20 and to allow the dental practitioner to drill, at the timeof corticotomy, first through the template 20 and then through thegingivae 83, cortical plate, and into the medullary bone.

The template 20 is complete when it has been created to fit at least aportion of the jawbone of the patient and when it also includes someindication as to where the safe areas 50 are located for performing aneedle corticotomy directly through the gingivae 50. That indication, asdescribed herein, may include providing an outline of each region 22-46,a cut-out (i.e., removed portion from the template 20) of each region22-46, or predrilled holes in the template 20 within each region 22-46.

As indicated, identification of the cortical safe areas 50, which arethe delineated areas of interproximal bone between each tooth 62 and theadjacent tooth 64, and then the accurate projection of these safe areas50 as each region 22-46 to the surgical template 20 are critical to theinvention.

After the needle corticotomy has been performed, preferably, an aligner(a device intended to apply orthodontic forces to reposition at leastone of the teeth) or braces are applied, the patient is released, andthe gingivae 83 are allowed to heal. The patient preferably returns in afew days to confirm that healing is properly occurring.

It is possible to delay the application of orthodontic forces until alater time. However, it is preferred to apply the orthodontic forcessooner rather than later. Any preferred orthodontic device is used(i.e., applied) to begin to apply a force to the teeth that requirerepositioning. RAP occurs in response to the needle corticotomy in theaffected regions 22-46 and rapid movement of those teeth also occur inresponse to the force that is applied to the softened cortical plate bythe teeth.

The orthodontic device and movement of the teeth are periodicallymonitored and the orthodontic device is adjusted or replaced with amodified orthodontic device to ensure that constant pressure ismaintained and applied to the teeth to reposition them as quickly aspossible. Once the teeth have reached their desired position, noadditional force attempting to move them a further amount is applied tothem. Orthodontic devices may then be utilized, as desired, to retainthe now quickly and properly repositioned teeth in their desiredposition until the cortical plate re-hardens and secures the teeth inposition from that time forward.

Prior to the instant invention, it has not been possible to perform aneedle corticotomy safely through the gingivae 83, absent firstperforming a mucoperiosteal flap procedure to expose the cortical plate.The time required to perform the mucoperiosteal flap procedure, theexpense associated with it, the discomfort it causes to the patient, theadded risks or infection, and the fear associated with these elementsare all eliminated by the instant invention. The gingivae 83 are ableheal readily from the punctures associated with the needle corticotomythat occur in the regions 22-46. No suturing is typically required.

It is expected that future scientific advancement will include evenfurther modification to the instant invention, thereby allowing thedentist to perform the needle corticotomy without the use of a surgicaltemplate and/or drills as previously described.

The use of a monitor viewing screen at the site of the operationdisplaying an internal view of the patients jawbones making it possibleto place the drill, X-tip or even to use a laser as a boring instrumentor other type of cutting device and to do so without the use of thesurgical template 20, while still penetrating through the gingivae 83and cortical plate to the inner medullary bone to provide the necessaryblood supply to the cortical plate to induce RAP, or the regionalacceleratory phenomenon, to occur while avoiding all landmarks.

Likewise, new and better methods of correcting orthodontic malocclusions(i.e., orthodontic devices) will be used by dentists (i.e., toreposition the teeth) and when available for use, are of course suitablefor use with the instant invention after the needle corticotomy has beenperformed.

Therefore, any method that induces RAP combined with new orthodonticmethods is included in this invention which does not require either amucoperiosteal flap or insertion or bone grafting materials.

Referring now to FIG. 10 is shown a cross-sectional view of a modifiedtemplate, identified in general by the reference numeral 200. Toillustrate a first method of regulating depth and direction refer to aportion of the drawing identified by bracket 202. It is preferred,though not required, that the thickness of the modified template 200 befairly constant if the first method is employed. It is required,however, that the thickness of the modified template 20 not exceed aminimum amount required to permit drilling of the deepest required hole.The reason for this is made apparent in the following discussion.

According to the first method, a short conduit 204 is included in themodified template 200 as and where needed within any given one or moreof the regions 22-46. As and where needed, a long conduit 206 issimilarly provided. The short and long conduits 204, 206 are formed ofany preferred material including metal or plastic or any other preferredtype of material.

The short conduit 204 cannot be shorter than the thickness of themodified template 200. This is to ensure that the deepest hole that isrequired to be drilled into any of the regions 22-46 will penetrate intothe medullary bone the desired amount when a particular length of drillor needle is used.

Conversely, the long conduit 206 cannot be any longer than would permitthe chosen needle or drill to penetrate the minimum required amount intothe medullary bone.

When the first method for regulating depth is used, a particular lengthdrill or needle is specified. The length of each conduit 204, 206 isselected at each particular drill site after analysis of the image files(i.e., the CD ROM file) or other detection means to determine thelocation of the landmarks to avoid. Analysis of the thickness of thecortical plate and of the medullary bone are factored in to determinethe optimum depth of drilling.

The speed advantage thus obtained is apparent. The practitionerperforming the needle corticotomy merely selects one length of drill orneedle, inserts it into the instrument, and then proceeds in rapidsuccession to create all of the punctures by inserting the drill orneedle into each conduit 204, 206 until drilling has penetrated the fulldepth allowed by each particular conduit 204, 206.

Not only is the drilling depth automatically regulated and varied foreach and every puncture location, but the direction of drilling is alsoensured, thereby preventing any possibility that inadvertence couldcause the drill or needle to wander in an unwanted direction andpossibly contact a landmark.

If it is deemed especially important to avoid a particular landmark and,nevertheless accomplish a required puncturing, an angled conduit 208 isprovided in the modified template 200. The angled conduit 208 includesthe desired length and is other than normal with respect to a surface ofthe gingivae 83.

The second method of regulating depth and direction of drilling (i.e.,puncturing the gingivae 83, cortical plate, and entering into themedullary bone) is accomplished as shown by referring to a portion ofthe drawing identified by bracket 210. The thickness of the modifiedtemplate 200 is accordingly varied to produce a similar regulation tothe depth of drilling as described above.

At a first thinner location of the modified template 200, a firstshorter embedded conduit 212 is included that is flush with the twoopposite surfaces of the modified template 200.

Similarly, at a second thicker location of the modified template 200, asecond longer embedded conduit 214 is included that is also flush withthe two opposite surfaces of the modified template 200.

The dentist similarly is instructed to use a drill or needle of aparticular length and to drill, in succession, through all of theembedded conduits 212, 214 in the modified template 200. Any of theembedded conduits 212, 214 may of course be angled away from normal, ifdesired.

With either method, it is of course possible to require a change ineither the length or diameter (another variable that is regulated by theconduits 202, 204 or by the embedded conduits 212, 214) of the drill orneedle, should that be necessary to accommodate anomalies in theanatomic features of the patient.

Not specifically shown, but apparent after the instant disclosure, amodification of the second method of regulating depth and direction(i.e., varying the thickness of the modified template 200) includes theomission of the embedded conduits 212, 214 from the modified template200.

It is not generally preferred that both methods for controlling depthand direction be employed on the same region of the modified template200, although it is possible. It is generally preferred to construct anyversion of the modified template 200 so that it utilizes only one, butnot both, of the methods for controlling depth and direction.

It is possible, however, to construct the modified template 200 usingboth methods, one at certain regions 22-46 and the other at a remainderof the regions 22-46. For example, the conduits 202, 204 may irritatethe tissues of the cheek farther back in the mouth and may therefore notbe used toward the rear but instead proximate the front teeth, while theactual depth of the modified template 200 may be varied in these morerearward portions to lessen discomfort to the cheek.

Referring again to FIG. 9, it is possible to eliminate the need foreither the template 20 or the modified template 200 by providing areal-time indication of where to drill through the gingivae 83. Animaging device 300 (such as x-ray) is providing constant real-time dataas to the subsurface structures which are being received by a receivingdevice 302 that is appropriately positioned.

The receiving device 302 conveys the data to a computer 304 whichprocesses the data, determines landmarks to avoid (by comparison with adatabase) and projects a laser beam 306 from a laser 308 onto a region22-46 where drilling is to occur. The dentist then pushes a button (notshown) which informs the computer that that particular hole has beendrilled. The computer 304 then offsets the laser beam 306 to anotherlocation within the same region 22-46 or if that region is complete tothe next hole to drill in the next region 22-46.

It is important to note that the number of penetrations that arerequired at any one of the regions 22-46 include a sufficient number ofpenetrations through the cortical plate and into the medullary bone andat preferred spaced apart intervals to cause a sufficient softening ofthe cortical plate. While generalizations may be made, this can alsovary from patient to patient.

Also shown in FIG. 9, are a few of the plurality of bore holes (i.e.,punctures) 350 that have been accomplished in the region 36 where needlecorticotomy is occurring.

Referring also to the side is shown a first color code 352 and below ita second color code 354 that are provided on the template 20, asdesired. The first color code 352 includes a different color than thesecond color code 354. Each color code 352, 354 instructs the dentist tomake the punctures that are proximate any given one of the color codes352, 354 at a particular depth. The preferred depth for each hole orgroup of holes is determined by analysis of the anatomical features andlandmarks and is optionally provided as a guide for the dentist tofollow.

Another expected, common method of utilizing the instant invention is toprovide the template 20 as the first template covering a full arch toallow for a full corticotomy when desired. This is to assist for generaltypes of tooth movement, such as expansion or retraction.

A second and, as desired, a plurality of successive templates (notshown) are created at various stages of the aligners or braces wherecertain desired tooth movements need additional corticotomy treatment tofacilitate optimally rapid tooth movement. The second and successivetemplates are typically created at the beginning of difficult toothmovements, such as rotations, closing large spaces, applying a torquefor angulation of roots, eruption, and distalizing or mesializing ofteeth.

The second and successive templates can also include a full arch,anterior arch, quadrant (i.e., half arch), or any portion of arch, asdesired, depending primarily on the amount of corticotomy that isrequired to keep tooth movement progressing as rapidly as possible.

The invention has been shown, described, and illustrated in substantialdetail with reference to the presently preferred embodiment. It will beunderstood by those skilled in this art that other and further changesand modifications may be made without departing from the spirit andscope of the invention which is defined by the claims appended hereto.

1. A method for performing a needle corticotomy on a patient without amucoperiosteal flap procedure, comprising the steps of: a) identifying asafe area to penetrate into a medullary bone; b) indicating said safearea when said corticotomy is performed on a gingivae of said patient;c) providing a template and disposing said template over at least aportion of the gingivae of said patient during said corticotomy, andwherein said template includes an indication of said safe area; d)indicating at least one region that is disposed between two adjacentteeth and over an interproximal bone area of a cortical plate andwherein said at least one region is disposed over a portion of themedullary bone that does not include any anatomical features orlandmarks that must not be contacted during said needle corticotomy; ande) pre-drilling at least one hole through said at least one region ofsaid template, thereby providing at least one pre-drilled hole in saidat least one region that corresponds with said at least one region. 2.The method of claim 1 including the step of removing said at least oneregion from said template, thereby providing a cut-out area thatcorresponds with said at least one region.
 3. The method of claim 1including the step of providing a visual marking around said at leastone region of said template, thereby providing an outline area thatcorresponds with said at least one region.
 4. The method of claim 1including the step of providing a plurality of holes through said atleast one region of said template.
 5. The method of claim 1 includingthe step of further indicating a preferred depth of at least one holethat is to be drilled in said at least one region.
 6. The method ofclaim 5 including the step of color-coding said at least one hole,wherein said color code corresponds with said preferred depth.
 7. Themethod of claim 5 including the step of including means in said templateto regulate the depth a drill may penetrate into said at least oneregion.
 8. The method of claim 7 including the step of providing aplurality of conduits that are flush with a surface of gingivae on afirst side of said template and which each extend away from saidtemplate on an opposite side thereof, and wherein each of said pluralityof conduits includes a particular length, and wherein each of saidconduits is for use with a particular length of drill or needle, andwherein a longer conduit further limits the depth said drill or needlemay penetrate into said at least one region and wherein a shorterconduit permits said drill or needle to penetrate into said region agreater depth than said longer conduit.
 9. The method of claim 7including the step of varying the thickness of said template over saidgingivae as desired within each of said at least one region or from afirst of said at least one region to a second of said at least oneregion, and wherein when a given length of drill or needle is used, athicker portion of said template limits the depth that said drill orneedle is able to penetrate into said at least one region than occurswhen said drill or needle is used at a thinner portion of said template.10. The method of claim 9 including the step of pre-drilling at leastone hole through said template at said at least one region.
 11. Themethod of claim 10 including the step of inserting a conduit into saidat least one pre-drilled hole in said template.
 12. The method of claim1 including the additional step of including means in said template fordetermining a direction a drill or needle is allowed to travel into saidat least one region.
 13. A method for performing a needle corticotomy ona patient without a mucoperiosteal flap procedure, comprising the stepsof: a) identifying a safe area to penetrate into a medullary bone; andb) indicating said safe area when said corticotomy is performed on agingivae of said patient, and including the additional steps ofproviding a template and of disposing said template over at least aportion of the gingivae of said patient during said corticotomy, andwherein said template includes an indication of said safe area, andincluding the step of indicating at least one region that is disposedbetween two adjacent teeth and over an interproximal bone area of acortical plate, and wherein said at least one region is disposed over aportion of the medullary bone that does not include any anatomicalfeatures or landmarks that must not be contacted during said needlecorticotomy, and including the step of pre-drilling at least one holethrough said at least one region of said template, thereby providing atleast one pre-drilled hole in said at least one region that correspondswith said at least one region.
 14. A method for performing a needlecorticotomy on a patient without a mucoperiosteal flap procedure,comprising the steps of: a) identifying a safe area to penetrate into amedullary bone; and b) indicating said safe area when said corticotomyis performed on a gingivae of said patient, including the additionalsteps of providing a template and of disposing said template over atleast a portion of the gingivae of said patient during said corticotomy,and wherein said template includes an indication of said safe area,including the step of indicating at least one region that is disposedbetween two adjacent teeth and over an interproximal bone area of acortical plate and wherein said at least one region is disposed over aportion of the medullary bone that does not include any anatomicalfeatures or landmarks that must not be contacted during said needlecorticotomy, including the step of further indicating a preferred depthof at least one hole that is to be drilled in said at least one region,including the step of color-coding said at least one hole, wherein saidcolor code corresponds with said preferred depth.
 15. A method forperforming a needle corticotomy on a patient without a mucoperiostealflap procedure, comprising the steps of: a) identifying a safe area topenetrate into a medullary bone; and b) indicating said safe area whensaid corticotomy is performed on a gingivae of said patient, includingthe additional steps of providing a template and of disposing saidtemplate over at least a portion of the gingivae of said patient duringsaid corticotomy, and wherein said template includes an indication ofsaid safe area, including the step of indicating at least one regionthat is disposed between two adjacent teeth and over an interproximalbone area of a cortical plate and wherein said at least one region isdisposed over a portion of the medullary bone that does not include anyanatomical features or landmarks that must not be contacted during saidneedle corticotomy, including the step of further indicating a preferreddepth of at least one hole that is to be drilled in said at least oneregion, including the step of including means in said template toregulate the depth a drill may penetrate into said at least one region.